Atlas FDA

AMPLATZ GOOSE NECK SNARE KIT/ CATHETER

FDA 510(k) clearance K972511 · decided 1998-03-06

Clearance details

K-number
K972511
Device name
AMPLATZ GOOSE NECK SNARE KIT/ CATHETER
Applicant
Microvena Corp.
Decision
Substantially Equivalent
Date received
1997-07-03
Decision date
1998-03-06
Days to decision
246 days
Clearance type
Traditional
Product code
DXE
Device class
2
Regulation number
870.5150
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
White Bear Lake, MN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Amplatz Goose Neck Snare Kit, 6 Fr, Lot 1650307, REF: GN3000, Use By 2009-09-01, Sterile E recall (Z-0992-2007)Ev3, Inc2007-07-11